This event is being reported via the tvt registry.Exemption number e2019001.The device was not returned for analysis.Additionally, a review of the lot history records for the lots could not be conducted, because the lot numbers were not provided.Based on the information reviewed, a conclusive cause for the reported patient effect, and the relationship to the device, if any, cannot be determined.There is no indication of a product issue with respect to manufacture, design, or labeling.The unique device identification (udi) is unknown as the part and lot numbers were not reported.
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This is being filed to report the unplanned intervention.It was reported through transcatheter valve therapy (tvt) registry data that a mitraclip device may be related to adverse events which are considered serious injury.The relationship of the adverse events to the mitraclip devices could not be determined based on the data received from the registry.Reportedly, 1 day post procedure, a device related event occurred.The next day, the patient underwent mitral valve reintervention.No additional information was provided.
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